IRB Determination (24FT)

STARS Tracking Number: 0900f3eb8231471b

NCEZID Tracking Number:

042524JY

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

Primary contact

Baseline description of nationally representative hospital system approach to collection of Race,
Ethnicity, and Language data and development of standard practice across participating sites

Janine Young

Division/Branch

DHQP/SB

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not require
submission to CDC’s Human Research Protection Office. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]

✔ Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.
Project is deemed not to be research under the following provision. IRB review is not required.
Select, if applicable

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this activity is to assess the baseline approach that each CoLab has for collecting REaL and
interpreter use data in each health system. The data collection will consist of sending a short REDCap
survey to SDOH leads and Chief Medical Information Officers at NHSN CoLab sits. This data will be used for
developing standard practice across interested CoLab sites so that NHSN can begin to evaluate validated
REaL and interpreter use data as they relate to HAIs. Results will be published and presented. As the
purpose of this activity is to assess the needs for a standardization of programmatic activities, it is consistent
with a non-research needs assessment program evaluation. This activity is not designed to contribute to
generalizable knowledge.
Additional considerations

Additional requirements

Changes in the nature or scope of this activity may impact the regulatory determination. Please discuss any changes with
your NC Human Subjects Advisor before they are implemented.
Reviewed by

James Peterson, PhD

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2024.04.25 11:50:19 -04'00'

Title

Human Subjects Advisor

Date 4/25/2024